Smart Solutions for Modern

GxP Validation

The definition: "Continuous validation is providing documented evidence to certify that an app not only met the pre-established acceptance criteria, but "continuous" to meet thus mitigating the risk of unknown changes." Continuous validation is not just a "point in time" validation. It is a type of validation which connects various points in time (initial, patch, upgrade validation) with continuous smoke and regression testing. This feature provides the documented evidence that the an app worked well not just at discrete points in time in the past, but continues to function as expected in the present. This also mitigates the risk of any change in either the IaaS/PaaS layer (for cloud apps) or the underlying IT infrastructure (for on-prem apps) that can potentially alter its behavior.

xLM's QMS is based on industry standards as well as applicable GxPs. xLM's QMS is a robust framework based on ISO 9001:2015, GAMP 5 and ASTM E2500 as well as FDA 21 CFR Part 11, EudraLex Annex 11. xLM's QMS enables us to deliver our managed services that not only meets, but exceeds the expectations of regulatory agencies in the USA, Europe and Japan.

xLM QMS's elements are mapped to 21 CFR 820 QSR.

cIV is an AI-powered continuous validation platform that aims to revolutionize software validation by introducing autonomous agents that can generate an URS, develop test cases and execute them with very minimal human input. It employs advanced AI algorithms to enhance test coverage, reduce false positives and negatives while adapting to application changes. The platform automates the entire Software Development Life Cycle (SDLC), from generating User Requirements Specifications (URS) to executing tests, thereby minimizing manual effort and increasing reliability. cIV is organized into three (3) distinct modules: URS Generation, Test Case Generation, and Test Automation - all accessible via the browser.

cIV leverages advanced language models to automate the creation of User Requirements Specifications (URS), generate detailed test cases, and produce Test Plan Execution (TPE) reports. cIV is built on xLM's Continuous Intelligence platform. The input can be as simple as an user manual. Our agents can navigate the System Under Test (SUT) leveraging its auto exploration capabilities. The accuracy of the output can be further increased by simply walking thru test case scenarios using the built-in recorder function. The above inputs are catalogued into a knowledge graph which forms the basis for the agents to build the artifacts. The process follows these steps: Step 1: Autogeneration of the knowledgebase by cIV agents; Step 2: cIV Agent-1 generates the URS in minutes; Step 3: cIV Agent-2 takes the approved URS and generates detailed test cases; Step 4: cIV Agent-3 Executes the test cases and delivers a GxP compliant TPE in PDF format.

Leveraging advanced language models and Retrieval-Augmented Generation (RAG) technology, cIV delivers exceptional User Requirement Specification (URS) documentation. The system combines sophisticated AI capabilities with vector databases to accomplish two critical objectives: retrieving pertinent information and transforming it into meticulously structured, GxP-compliant specifications. This innovative automation not only ensures consistency across documents but also significantly reduces human error while capturing all user requirements with precision and thoroughness.

After URS validation, cIV streamlines the requirements management process through sophisticated AI-driven tools that effectively categorize and consolidate specifications. The system then transforms these consolidated requirements into comprehensive test cases, structured in both BDD and web-action formats. Leveraging its robust knowledge repository and specialized information extractors, the platform systematically generates step by step test cases to fulfill the corresponding requirements. This methodical approach ensures thorough test coverage while maintaining precise alignment with user expectations and requirements.

The cIV Test Automation Module streamlines test execution through sophisticated parsing of uploaded test cases and seamless interaction with the System Under Test (SUT). Leveraging advanced cross-browser testing tools, it meticulously validates application behavior while generating comprehensive, GxP-compliant Test Plan Execution (TPE) reports. Through its agentic framework, the module ensures exceptional precision and operational efficiency throughout the entire testing lifecycle.

cIV demonstrates exceptional future-readiness through its sophisticated AI-driven architecture. The platform dynamically adapts to evolving application environments, consistently maintaining precision in User Requirement Specifications (URS), test cases, and automation scripts. This inherent adaptability establishes cIV as a powerful and sustainable solution for long-term software validation needs. During the execution step, the test automation code is dynamically generated based on the current SUT and does not rely upon any pre-generated code.

Contact us to discover how cIV can transform your compliance and validation strategy, or visit the xLM blog and podcast for updates on AI in GxP and FDA expectations.